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| |  Nateglinide Appears To Reduce HbA(1c) Comparable to Metformin EAST HANOVER, N.J. -- November 17, 2000 -- Nateglinide (Starlix®, Novartis Pharmaceuticals Corporation) reduced HbA(1c) levels comparable to metformin in patients with type 2 diabetes on no previous drug therapy regimen, according to data from a new subanalysis of data published in the November issue of Diabetes Care. According to the study, in a subset of patients (N=197) not previously treated with hypoglycemic drugs prior to study entry, the HbA(1c) level decrease from baseline was 0.8% for both the nateglinide (120 mg) and metformin (500 mg) monotherapy groups. In addition, in a separate subgroup of patients whose entry-level HbA(1c) was greater than or equal to 9.5%, the difference from placebo was 1.4%, 1.5% and 2.5% in the nateglinide, metformin and combination groups respectively. These findings are from a randomized, double-blind, parallel-group, fixed-dose placebo controlled study involving 701 patients with type 2 diabetes. The study was designed to evaluate the effects of nateglinide, as monotherapy and in combination with metformin, on glycemic control, including postprandial glucose control, and to assess the tolerability and safety of these treatment regimens in patients with type 2 diabetes. "Results of the study indicate that, in this subgroup, nateglinide and metformin comparably improved overall control of blood sugar levels, but by different mechanisms," said Edward Horton, M.D., principal investigator and vice president and director of clinical research at Joslin Diabetes Center in Boston. "Nateglinide appeared to exert its effect by reducing mealtime glucose spikes, the elevation of blood sugar levels during or after eating. Metformin, on the other hand, works by reducing fasting plasma glucose, the measurement of glucose in the absence of food." In this study, minimal weight gain (< 1 kg) and a low incidence of mild hypoglycemia (< 2%) were the only treatment-related side effects associated with Starlix monotherapy. The major side effect associated with metformin monotherapy was diarrhea (20%). Study Design. In this double-blind, randomized, placebo-controlled study, patients were placed in one of four treatment groups: nateglinide at a dose of 120 mg AC (before meals); metformin 500 mg TID (three times a day); nateglinide at a dose of 120 mg AC combined with metformin 500 mg TID; and placebo. Patients were over 30 years of age and had been diagnosed with type 2 diabetes for at least three months. They were treated with diet alone during a four-week washout period prior to enrollment. After enrollment there was a four-week placebo run-in, after which patients with HbA(1c) levels between 6.8% and 11.0% (despite dietary intervention and with a fasting plasma glucose [FPG] level of less than or equal to 270 mg/dl) were placed in one of the treatment groups. Starlix is a derivative of the amino-acid d-phenylalanine that is chemically and pharmacologically distinct from any other oral antidiabetic currently available. Novartis Pharmaceuticals Corporation submitted a new drug application (NDA) to the U.S. Food & Drug Administration for Starlix on December 17, 1999. The NDA includes an indication for Starlix as monotherapy (60, 120 and 180 mg doses) and in combination with metformin. Note: Dr. Edward Horton has received honoraria on occasion as a member of a Novartis diabetes advisory group.
Related Link: Novartis Pharmaceuticals Corporation.
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